Suture Techniques to Reduce the Incidence of Incisional Hernia: LTFU STITCH Trial

Summary

Rationale: Incisional hernias (IH) are a frequent complication after abdominal surgery. Prevalence of an IH varies depending on the previous abdominal procedure but could be as high as 70% in high-risk patients after open surgery. To investigate different fascia closure techniques in the prevention of IHs, the STITCH trial (NCT01132209) was designed. The study compared two different closure techniques for closure of a midline incision in adult patients undergoing an elective abdominal laparotomy. Patients were randomly assigned to the intervention group (small bites 5 mm x 5 mm) or the control group (large bites 1 cm x 1 cm). The study showed that small bites are much more effective than large bites in the prevention of an incisional hernia when closing a midline incision.

So far, it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group.

Objective: The primary objective of this study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial. The secondary objectives are to measure quality of life (QoL), body image and cosmetic results, and abdominal wall function through questionnaires and physical examination in those patients who are still alive.

Conditions

• Surgery
• Incisional Hernia
• Wound Infection
• Fascial Dehiscence
• Pain
• Quality of Life

Interventions

PROCEDURE

Small bites technique

Closure of the fascia after midline laparotomy using a slowly resorbalbe 2.0 suture, with 0.5 cm bites, and 0.5 cm between the stitches, at least resulting in a 1:4 wound length:suture length ratio.

PROCEDURE

Conventional large bites closure

Closure of a midline laparotomy using a slowy resorbable thick suture (e.g. PDS loop) with large bites and large steps (\>= 1 cm).

Sponsors & Collaborators

• Franciscus &Vlietland

  collaborator OTHER

• Elisabeth-TweeSteden Ziekenhuis

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Spaarne Gasthuis

  collaborator OTHER

• Meander Medisch Centrum

  collaborator OTHER

• Red Cross Hospital Beverwijk

  collaborator OTHER

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Pieter J Tanis · Erasmus Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2024-03-01

Completion

2024-10-31

Countries

• Netherlands

Study Locations