The modified cross-suture technique for loop stoma reversal: A single-center randomized controlled study

doi:10.21203/rs.3.rs-3131904/v1

Objective:

To explore the application effect of modified cross-suture technique in loop stoma reversal.

Methods:

From June 2019 to December 2022, patients with loop stoma reversal were divided into observation group (35 cases) and control group (25 cases) according to the numerical random method. According to the different methods of skin suture, the observation group was treated with modified cross-suture technique, and the control group was treated with interrupted suture method. The operation time, intraoperative blood loss, postoperative out-of-bed time, postoperative exhaust time, postoperative eating time, primary healing time, incision infection rate, incision healing time after incision infection, postoperative hospital stay, postoperative early pain score, and overall patient satisfaction score were compared between the two groups.

Results:

There were no significant differences in age, gender, body mass index, American Society of Anesthesiologists, disease history, remission interval, operation time, intraoperative blood loss, and primary healing time between the two groups (P>0.05). The postoperative out-of-bed time, postoperative exhaust time, postoperative eating time, postoperative hospitalization time, hospitalization cost, postoperative early pain score, and incision infection rate in the observation group were all lower than those in the control group (P<0.05). The healing time after incision infection in the observation group was shorter than that in the control group (P<0.05). The overall satisfaction score of patients in the observation group was higher than that in the control group (P<0.05).

Conclusions:

The modified cross-suture technique is a suitable incision treatment method for loop stoma reversal.

Suture technique

Loop stoma reversal

Surgical Wound Infection

Trauma, low rectal cancer, rectal cancer surgery after neoadjuvant chemoradiotherapy, and emergency bowel surgery often require ileum or colostomy to divert feces; appropriate stoma plays an important role in reducing the incidence of anastomotic leakage, reducing the incidence of abdominal infection and reducing the number of secondary operations¹. Most patients underwent stoma reversal within 1 year. Incision infection is the most common complication of stoma reversal, with an incidence rate as high as 41%, and it is difficult to prevent^{2, 3}. Incision infection delays incision healing time prolongs hospital stay and increases patients’ economic burden and pain⁴. To reduce the rate of incision infection, scholars at home and abroad have proposed many methods, such as povidone-iodine irrigation of incisions, subcutaneous implantation of gentamicin sponge, subcutaneous placement of drainage tubes, vacuum-assisted closure therapy (VSD), secondary sutures, delayed primary sutures, and purse string sutures, etc; however, the optimal suture method remains controversial⁵. The author's team successfully employed the modified cross-suture technique in conjunction with a postoperative inverted trapezoidal pressure bandage to effectively manage abdominal wall incisions during loop stoma reversal procedures, yielding favorable clinical outcomes.

2.1 1. Patients.

We enrolled 60 patients with loop stoma reversal from June 2019 to December 2022. They were divided into the observation group (35 cases) and the control group (25 cases) randomly. According to the different methods of skin suture, the observation group was treated with the modified cross-suture technique, and the control group was treated with the interrupted suture method. The research was approved by the Ethics Committee of our hospital( 2021 − 125). All patients signed a consent form for surgery. Inclusion criteria: (1) Patients with complete medical records and patients with indications and willingness for intestinal stoma restoration; (2) Preoperative enhanced CT and colonoscopy without signs of tumor recurrence and metastasis and anastomotic stricture; (3) Patients with basically normal anal defecation function as shown by preoperative anorectal manometry and defecography. Exclusion criteria: (1) Patients with other malignant tumors, colitis, or severe mental illness; (2) Patients with American Society of Anesthesiologists (ASA) grading IV-V; (3) Severe infection or ulceration of peristomal tissue; (4) Unable to cooperate with the survey.

2.2 Variables.

This includes various parameters such as operation time, intraoperative blood loss, time to resume mobility after surgery, time to achi operation time, intraoperative blood loss, postoperative out-of-bed time, postoperative exhaust time, primary healing time, incision infection rate, incision healing time after incision infection, postoperative hospital stay, hospitalization cost, postoperative early pain score (postoperative 24h, 36h, and 72h), and overall patient satisfaction score, among others. The diagnosis of incision infection was based on the “Diagnostic Criteria for Hospital Infection” (trial) promulgated by the Ministry of Health in 2001. Pain score was scored by numerical rating scale (NRS), 0 points: no pain; 1–3 points: mild pain (sleep not affected); 4–6 points: moderate pain (sleep affected); 7–10 points: severe pain (severely affects sleep). Patient’s overall satisfaction score⁶: A satisfaction questionnaire was used 3 months after the operation to evaluate satisfaction from 6 aspects, including cosmetic aspect, scar appearance, postoperative pain, healing time, the difficulty of incision care, and limitation of daily activities. 1 point represented very Dissatisfied, and 5 points means very satisfied. All ratings are added together for a total score, with 6 points representing very dissatisfied and 30 points representing very satisfied.

2.3 Operation.

2.3.1 Observation group (modified cross-suture technique): (1) The proximal and distal ends of the enterostomy were sutured with purse-string suture (mousse suture 0). (2) Four-pointed star-shaped incision marking: mark the edge of the original stoma on the skin, and use the 3, 6, 9, and 12 o'clock marks as the vertices of the 4 triangles, and connect the vertices with the skin around the stoma. (3) Make a four-pointed star-shaped incision along the marked line, separate the skin around the stoma intestine, and then cover the stoma intestine with a purse-string suture at the vertices of 4 triangular skin tissues. (4) After loosening the adhesion around the stoma, insert the incision protector; continue to free the intestinal tubes at both ends of the stoma for 10-15cm. (5) After resection of the stoma intestine, side-to-side or end-to-side anastomosis was performed to restore the continuity of the intestine; the seromuscular layer was sutured to reinforce the anastomotic stoma and close the mesangial hole (GL122 3 − 0). (6) Properly dissociate the subcutaneous fat layer and the anterior sheath of the rectus abdominis by tissue separation technique. (7) Close the peritoneum and rectus sheath with continuous full-thickness sutures (PDP990G 0). (8) Suture the subcutaneous fat layer and dermis layer (GL122 3 − 0) with purse-string suture, tighten and tie the knot according to the tension of the incision, and keep a hole with a diameter of about 1.0cm and 0.5cm in the center respectively. (9) Suture the 4 sides of the cross intermittently with 1–2 stitches (mousse thread 3 − 0), and place a rubber strip in the center of the small hole. See Fig. 1.

2.3.2 Control group (interrupted suture method): (1) Make a fusiform incision along the 0.2cm skin around the stoma. (2) The same as the observation group, free and anastomotic intestinal tube. (3) Close the peritoneum and rectus sheath with continuous full-thickness sutures (PDP990G 0). (4) Intermittent full-thickness suture of the skin (mousse suture 3 − 0), and a rubber drainage strip placed under the skin.

2.3.4 Postoperative treatment

An inverted trapezoidal sterile dressing is used to cover the incision, and a high-elastic abdominal band is bandaged under pressure(Fig. 2). Postoperative antibiotics were used prophylactically for 1 day. The dressing was changed 24 hours after the operation, the drainage strip was removed 72 hours after surgery, and the sterile dressing was replaced every 2 to 3 days according to the exudation of the incision. If the incision is infected, such as incision swelling, purulent secretions, etc., it should be drained normally, and the sutures should be removed intermittently if necessary, and daily disinfection and sterile dressings should be replaced, and the exudate should be submitted for bacterial culture. According to the recovery of intestinal function after the operation, food intake was gradually taken. Discharge criteria: Exhaust and defecation, no discomfort after eating, no obvious pain in the incision. After discharge, the sterile dressing was changed every other day until the incision was free of secretion. Photos of the incision should be retained during each dressing change to judge the healing of the incision. Incision healing standard: The incision is covered by epithelium, with no cracking, no ulceration, no redness, swelling, and exudation, and the standard for stitch removal is reached. The time of incision infection and incision healing time was recorded after operation.

2.4 Statistical analysis.

Statistical software SPSS 26.0 was used for data processing. Categorical data of all patients were expressed as cases (n) and the comparison was performed by χ2 test or Fisher’s exact probability test. Continuous variables with normal distribution were presented as mean (standard deviation [SD]) and t-test was used for comparison between groups. P < 0.05 means the difference is statistically significant.

All patients in the two groups completed the operation successfully, without serious complications, unplanned reoperation, and death cases.

3.1 Clinical characteristics of the participants

There were no significant differences between the two groups in age, gender, BMI, ASA, history of smoking and alcohol abuse, underlying diseases, type of stoma, initial disease, and time interval of stoma closure (P>0.05). See Table 1 for details.

3.2 Comparison of perioperative outcomes

There was no significant difference in operation time, intraoperative blood loss, and primary healing time between the two groups (P>0.05); The postoperative out-of-bed time, postoperative exhaust time, postoperative hospitalization time, hospitalization cost, postoperative early pain score, incision infection rate in the observation group were all lower than those in the control group (P<0.05); The healing time of incision infection in the control group was longer than that in the observation group (P<0.05). See Table 2 for details.

3.3 Infection analysis

Analyzed from the type of stoma, regardless of colostomy or ileostomy, the incidence of infection in the control group was higher than that in the observation group, but the difference was not statistically significant (P>0.05); Analyzing the way of anastomosis, in the end-to-side anastomosis, the infection rate in the control group was higher than that in the observation group, and the difference was statistically significant (P<0.05); in the side-to-side anastomosis, the infection rate in the control group was also higher than that in the observation group, but the difference was not statistically significant (P>0.05). See Table 3 for details.

3.4 Comparison of overall satisfaction score of patients

The overall satisfaction score of the observation group was higher than that of the control group (P<0.05). See Table 4 for details.

Temporary enterostomy is usually used in colorectal surgery to reduce anastomotic leakage and reduce the risk of reoperation^{7, 8}; However, 30% of stoma patients will experience stoma-related complications⁹, such as skin irritation, prolapse, retraction, separation, stenosis, necrosis, fistula, parastomal hernia, etc. These complications affect patients’ daily activities and reduce their quality of life. It is usually recommended to complete the closure of the stoma after 8 to 12 weeks after the operation¹⁰, which allows the patient to have sufficient recovery time after the first operation, allowing the inflammation, edema, and adhesions in the abdomen and around the stoma to subside. However, there may still be complications in stoma closure surgery, mainly including incision infection, anastomotic leakage, intestinal obstruction, incisional hernia, etc, among which incision infection is the most common. The conventional methods to deal with incision infection are dressing change, debridement and drainage, and the healing time is usually 1 to 2 months. Different incision designs and suturing methods have certain effects on incision healing¹¹.

Surgeons have always been concerned about how to effectively mitigate the incidence of incision infections. According to relevant literature reports, the current main methods include: (1) Traditional interrupted layered suture method: Layered suture refers to suturing each layer of the abdominal wall sequentially. It was considered to be the standard method of abdominal wall suture in the past, but the operation is complicated, the operation time is long, and the risk of incision infection and dehiscence is relatively high. (2) Full-thickness suture method: Full-thickness suture refers to the one-time suture of abdominal wall tissue except skin. Recent studies^{12, 13} have shown that it can reduce the incidence of postoperative incision complications; compared with traditional layered suture, although the incision cavity is reduced, the gap in the subcutaneous layer still exists, which is still prone to effusion and even infection. (3) Subcutaneous indwelling drainage tube: Previous studies have found that non-suture of the subcutaneous fat layer combined with subcutaneous continuous negative pressure drainage is safe and effective¹⁴, which can draw out subcutaneous fluid in time and promote incision healing; combined with layered full-thickness suture, it can play a very good effect. However, the indwelling of the negative pressure drainage tube affects the early activities of the patient and is not conducive to the overall postoperative recovery. (4) Purse-string suture: Banerjee¹⁵ reported the purse-string suture technique, that is, after the rectus sheath is sutured, the subcutaneous tissue of the incision is purse-string sutured with 2 − 0 polypropylene suture, the central pore (5mm) is retained after knotted, and the suture is removed after 8–10 days. Studies¹⁶ have confirmed that compared with direct sutures, purse-string sutures can reduce the infection rate of incision, but the incision of purse-string suture is round, which is not conducive to the exposure of visual field. Moreover, the tension of the incision after purse-string suture is large, and there is a certain residual space under the incision, which leads to prolonged wound healing time. (5) Cross-suture method: In 2010, Lim et al.¹⁷ proposed the cross-stitch method for the design and suture of skin incisions in stoma retraction surgery for the first time. The general procedure was to make four triangular "mouth edge" shaped free resections around the intestinal tube of the stoma; to close the stoma, and the "mouth edge" shaped incision was sutured into a regular linear incision similar to sight, with a small drainage gap in the center of the incision. The skin incision design can not only increase the exposure of the operative field to reduce the risk of intestinal damage during the process of dissociated bowel, but also has low incision tension, shortened healing time, low infection rate, and small scars. However, this method ignores the importance of suturing methods other than the skin on incision healing; moreover, only the dermis is sutured with purse strings, leaving a large subcutaneous cavity, and when no drainage strips are placed, the drainage effect of the retained small holes is not ideal.

We have synthesized the current relevant incision treatment methods, and made the following improvements based on the cross-suture method: (1) After the bottom of the fat layer was properly separated, the fat layer and dermis were sutured with a purse-string suture with 3 − 0 absorbable suture, and the central pores with diameters of about 1.0cm and 0.5cm were retained to reduce the subcutaneous space. More tissue should be taken during suture to prevent avulsion. (2) A rubber drainage strip is placed in the small hole in the center of the incision to facilitate subsequent drainage. In addition to the above-mentioned modifications to the incision suture method, we have also made many improvements in the perioperative period of the preventive stoma: (1) The "one-stitch method"¹⁸ is adopted for preventive loop stoma in our unit, which is not only simple to operate during stoma, but also relatively light adhesion between the intestinal tube and its surrounding, which is conducive to the mobilization of intestinal tube during subsequent stoma closure; (2) Use No. 0 antibacterial Pudis suture (PDP990G) to continuously suture the peritoneum and the anterior and posterior sheath of the rectus abdominis in full thickness, which has high strength, uniform tension, and certain antibacterial effect; (3) If an infection is found in the incision, it usually only needs to remove the purse string of the dermisin in the observation group, which is simple and the care is convenient, which not only does not affect the quality of life of the patient but also does not significantly prolong the healing time of the incision. However, in the control group, the skin suture needs to be removed intermittently, so that the incision exposure is larger, the healing time is prolonged, and the follow-up incision care is more troublesome. (4) Covering the incision with inverted trapezoidal gauze combined with a high-elastic abdominal bandage after the operation not only further strengthens the fit between tissues, reduces the subcutaneous cavity, and facilitates the timely extraction of subcutaneous exudate; it also reduces the incision pain caused by activities, which is beneficial for patients to get out of bed early and promote the recovery of gastrointestinal function. We recommend wearing the high-elastic abdominal belt for half a year to reduce the incidence of postoperative incisional hernia.

In addition, this study still has certain limitations. Firstly, it is a single-center study, and secondly, the sample size is relatively small. In the future, we will collaborate with other centers to conduct studies with a larger sample size.

The modified cross-suture technique combined with postoperative incision compression dressing demonstrates significant advantages in minimizing postoperative incision infections and reducing associated pain. Moreover, it facilitates early mobilization after surgery, aids in the restoration of gastrointestinal function, and ultimately enhances overall patient satisfaction. This straightforward, secure, and efficacious approach to skin suture for loop stoma closure surgery offers a compelling solution.

Conflicts of interest:

The authors have no conflicts of interest to disclose.

Funding

This work was supported by the Scientific Research Fund Project of Hebei Provincial Health Commission (20220813).

Authors’ Contribution

Li-xiao Zhang and Jia-qi Kang wrote the main manuscript text; Zhi-bin Ye and Li-fei Zhang collected information about the study; Hong-yu Zhao prepared figures 1-2; and Liang Wei is the general leader of the subject. All authors reviewed the manuscript.

Data Availability Statement

The data supporting the findings of this study are available from the corresponding author, Wei Liang, upon reasonable request.

Declaration of competing interest

The authors have no conflicts of interest or financial ties to disclose.

Medical ethics

The study was approved by the Medical Ethics Committee of Hebei General Hospital (2021-125).

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Table 1 Comparison of baseline data of two groups of patients

	primary suture (n=25)	Modified cross-suture (n=35)	Statistics	P value
age(year)	61.36±14.53	61.2±10.41	0.049	0.961
gender(male, n)	12	16		0.861
BMI(kg/m²)	23.55±3.21	23.82±3.55	-0.271	0.763
ASA(n)			0.035	0.983
I	9	13
II	12	17
III	4	5
smoking history(n)	12	17	0.002	0.965
history of alcoholism(n)	7	10	0.002	0.961
diabetes(n)	5	9	0.266	0.606
hypertension(n)	6	16	2.961	0.085
COPD(n)	2	2	0.122	>0.999
chronic kidney disease(n)	2	3	0.006	>0.999
stoma types(n)			0	>0.999
colostomy	5	7
ileostomy	20	28
initial disease(n)			0.005	0.998
malignant tumor	17	24
benign disease	5	7
trauma(n)	3	4
Time interval of stoma closure(mon)	4.60±2.22	4.34±1.68	0.511	0.611

COPD, chronic obstructive pulmonary disease

Table 2 Comparison of perioperative conditions between the two groups of patients.

	primary suture (n=25)	modified cross-suture (n=35)	Statistics	P value
Method of anastomosis(n)			-	>0.999
end-to-side anastomosis	13	19
side-to-side anastomosis	12	16
operation time(min)	96.88±20.24	95.17±30.95	2.477	0.121
intraoperative blood loss(ml)	28.80±21.13	25.29±11.86	1.056	0.308
postoperative out-of-bed time	2.32±0.80	1.62±0.77	242	0.002
postoperative exhaust time	3.24±1.05	2.46±1.07	256.5	0.005
postoperative eating time	3.36±1.22	2.66±1.21	298.5	0.032
postoperative early pain score
24h	3.92±1.32	2.52±0.70	157.5	<0.001
48h	2.24±0.66	1.51±0.61	202.5	<0.001
72h	1.28±0.46	1.06±0.24	340	0.019
primary healing time	8.37±0.83	8.45±1.28	-0.263	0.794
incision infection(n)	6	3	-	0.145
incision healing time after incision infection	22.00±2.92	14.33±4.04	3.149	0.019
postoperative hospital stay(days)	8.68±3.08	7.37±1.88	2.0412	0.046
hospitalization cost(ten thousand yuan)	3.31±0.79	3.21±0.43	6.9377	0.011

Table 3 Comparison of infection rates between the two groups.

	n	Infection rate (number of infected cases/base number)		P value
	n	primary suture (n=25)	modified cross-suture (n=35)	P value
stoma type
colostomy	12	1/5	0/7	0.417
ileostomy	48	5/20	3/28	0.251
Method of anastomosis
end-to-side anastomosis	32	4/13	1/19	0.019
side-to-side anastomosis	28	2/12	2/16	>0.999

Table 4 Comparison of the overall satisfaction of the two groups of patients.

	cosmetic aspect	scar appearance	postoperative pain	healing time	difficulty of incision care	limitation of daily activities	total score
primary suture(n=25)	5(2)	5(2)	3(1)	5(2)	5(1)	5(1)	28(8)
modified cross-suture(n=35)	5(0)	5(0)	5(1)	5(0.5)	5(0)	5(0)	29(2)
P value	0.155	0.025	<0.001	0.175	0.362	0.219	0.002

No competing interests reported.

The modified cross-suture technique for loop stoma reversal: A single-center randomized controlled study

Status:

Version 1

Abstract

Figures

1. Introduction

2. Materials and Methods

2.1 1. Patients.

2.2 Variables.

2.3 Operation.

2.3.4 Postoperative treatment

2.4 Statistical analysis.

3. Results

3.1 Clinical characteristics of the participants

3.2 Comparison of perioperative outcomes

3.3 Infection analysis

3.4 Comparison of overall satisfaction score of patients

4. Discussion

5. Conclusion

Declarations

References

Tables

Additional Declarations

Status:

Version 1