STITCH Trial

Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial.

Clinical Question

In patients undergoing elective abdominal surgery with a midline laparotomy does fascial closer with small (5mm x 5mm) or large bites (1 cm x 1 cm) reduce the incidence of incisional hernia.

Bottom Line

Using small bites for fascial closer after midline laparotomy is more effective than large bite technique for preventing incisional hernias (13% vs. 21%, P=0.0220). There was no significant difference in rates of adverse events between groups.

Major Points

Incisional hernias are one of the most frequent complications of abdominal surgery, occurring between 10%-38% of patients . Hernias result most frequently with discomfort and pain, although can become strangulated, which is a surgical emergency .

Reduction of incisional hernias post-laparotomy is an area which was been well studied. Previous work has demonstrated that closure with a running technique is more effective than with an interrupted, and has become standard practice. Further, it has been demonstrated that a durable monofilament suture is the most effective in terms of hernia reduction,. Previous work has demonstrated that small bites are more effective than large bites , the STITCH Trial further supports these findings.

The authors have concluded that fascial closure using smaller bites is an effective way to reduce incisional hernias (13% in small bite group vs. 21% in the large bite group), with only a minimal increase in operative time (10 minutes vs. 14 minutes, P<0.001). Furthermore there was no increase in adverse effects or post-operative pain.

Guidelines

No guidelines have been published that reflect the results of this trial.

Design

• Prospective, multicentre, double-blind, randomized controlled trial
• N=560
  • Small bites (n=276)
  • Large bites (n=284)
• Setting: 10 surgical and gynaecological centres in the Netherlands
• Enrollment: October 20, 2009 to August 20, 2012
• Mean follow-up: 1 year
• Analysis: Intention-to-treat
• Primary outcome: Occurrence of incisional hernia

Population

Inclusion Criteria

• Elective abdominal surgery through a midline incision
• Age ≥ 18 years

Exclusion Criteria

• History of incisional hernia after midline laparotomy
• History of fascial dehiscence after midline laparotomy
• History of abdominal surgery through a midline incision in last 3 months
• Pregnant patients
• Participation in another trial

Baseline Characteristics

• Large Bites Group
  • Male sex: 49%
  • Mean age (years): 63 (54-71)
  • Mean BMI (kg/m^{"2"): 24 (22-27)}
  • Smoking: 23%
  • Diabetes mellitus: 14%
  • COPD: 10%
  • Cardiovascular disease: 41%
  • Corticosteriod use: 6%
  • Non-incisional hernias: 12%
  • Aneurysm abdominal aorta: 15%
  • Previous laparotomy: 15%
  • ASA 1: 20%
  • ASA 2: 64%
  • ASA ≥ 3: 15%
  • Preoperative chemotherapy: 26%
  • Preoperative radiotherapy: 19%
  • Gynaecological surgery: 14%
  • Upper gastrointestinal surgery: 31%
  • Lower gastrointestinal: 47%
  • Vascular surgery: 7%

Interventions

• Randomized to large bites or small bites group

• Small bites group
  • Placement of at least twice as many stitches as the incisional length (cm)
  • USP 2-0 PDS Plus II with a 31 mm needle
  • Tissue bite of 5mm with spacing of 5mm
  • Only fascial bites, fat and muscle were avoided
  • Suturing started at both ends of the incision and moved toward the centre
  • Overlap at least 2 cm from cranial and caudal sutures
  • Sutures separately knotted with an optional additional knot from both sutures
  • Number of stitches, wound length, and remaining suture measured, ratio of suture length to wound length calculated
  • Aim for suture length to wound length of 4:1
  • Follow up 1 month and 1 year post operatively

• Large bites group
  • USP 1 double loop PDS Plus II with a 48 mm needle
  • Tissue bite of 1 cm with spacing of 1cm
  • Only fascial bites, fat and muscle were avoided
  • Suturing started at both ends of the incision and moved toward the centre
  • Overlap at least 2 cm from cranial and caudal sutures
  • Sutures separately knotted with an optional additional knot from both sutures
  • Number of stitches, wound length, and remaining suture measured, ratio of suture length to wound length calculated
  • Aim for suture length to wound length of 4:1
  • Follow up 1 month and 1 year post operatively

Outcomes

Comparisons are intensive therapy vs. standard therapy.

Primary Outcomes

Comparisons large bites vs. small bites except where specified.

Rate of incisional hernia at 1 year

21% vs. 13%; P=0.0220; adjusted odds ratio 0·52, 95% CI 0·31–0·87; P=0.0131

Secondary Outcomes

Number of stitches

25 ± 10 vs. 45 ± 12; P<0.0001

Total length of used sutures (cm)

95 ± 34 vs. 110 ± 39; P<0.0001

Wound length (cm)

22 ± 5 vs. 22 ± 5; P=0.982

Ratio of suture length to wound length

4.3 ± 1.4 vs. 5.0 ± 1.5; P<0.0001

Time of fascial closure (min)

10 ± 4 vs. 14 ± 6; P<0.0001

Mean fascial defect (both groups)(cm)

3.4 cm ± 4.4

Hernia diagnosed by both physical and radiological exam

49%

Hernia diagnosed by only radiological exam

47%

Hernia diagnosed by only physical exam

3%

Size of hernia diagnosed by radiological examination alone vs. those diagnosed with by physical and radiological exam

2.4 ± 4.0 vs. 4.2 ± 0.5; P=0.0650

• Data for pain score (VAS), quality of life (EQ-5D), overall health (SF-36) were not included

Subgroup Analysis

• No subgroup effects were identified

Adverse Events

Patients with post-operative complications (total)

45% vs. 45%; P=1.000

Patients with ileus

12% vs. 10%; P=0.590

Patients with pneumonia

14% vs. 13%; P=0.710

Patients with cardiac event

11% vs. 9%; P=0.573

Patients with surgical site infection (total)

24% vs. 21%; P=0.419

Patients with superficial incisional surgical site infection

12% vs. 8%; P=0.207

Patients with deep incisional surgical site infection

4% vs. 3%; P=0.496

Patients with organ or space surgical site infection

8% vs. 10%; P=0.554

Burst abdomen

1% vs. 1%; P=0.444

Length of hospital stay (days)

14 ± 24 vs. 15 ± 35; P=0.585

Criticisms

• The follow up period of this study was 1 year, however previous studies have demonstrated that the rate of incisional hernias increases over time .
• 47% of hernias detected were found solely by radiological exam, the clinical significance of these hernias are unclear. The diagnosis of these small hernias resulted in an incidence which is higher than what has been previously demonstrated in the literature.
• The type of suture material was not controlled for, therefore it is unclear if the results from this work is due to smaller bites or the use of a different suture material
• It is unclear of these data are applicable to patients undergoing emergency laparotomies

Funding

• This study was funded by Erasmus University Medical Center and Ethicon
• Funders did not play a role in the study design, data collection, analysis, interpretation or creation of the manuscript
• Authors had full access fo data in the study and were responsible for the decision of whether to submit for publication