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

NCT06066385 | Unknown DMC

• 3 other identifiers: 9354IIS WC-2022-06MEC 2022-0652
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Surgery; Incisional Hernia; Wound Infection; Fascial Dehiscence; Pain; Quality of Life; Pathological Conditions, Anatomical; Infections; Postoperative Complications; Pathologic Processes

Outcome Measures

Primary Outcomes (1)

• Incisional hernia occurrence (and timeto incisional hernia outcome).

  Incisional hernia occurrence after operation clinical and/or radiological diagnosis.

  Patients will have a follow-up of up to 12 years, with most patients having a follow-up between 10 and 12 years.

Secondary Outcomes (5)

• Quality of life of the patient.

  Patients will have a follow-up of more than 10 years.

• Quality of life of the patient.

  Patients will have a follow-up of up to 12 years.

• Body image.

  Patients will have a follow-up of up to 12 years.

• Cosmetic results, cosmesis.

  Patients will have a follow-up of up to 12 years.

• AWF.

  Patients will have a follow-up of up to 12 years.

Study Arms (2)

Small bites suturing technique of the abdominal wall during midline laparotomy

EXPERIMENTAL

In the experimental group of 288 patients the small bites technique was applied with bite widths of 0,5 cm and inter suture spacing of 0,5 cm with the use of PDS plus ll 2-0 single suture material with a 31 mm needle placed in the linea alba. In the small bites technique, twice as many stitches will be placed per sutured cm, with a smaller needle and thinner suture material.

Procedure: Small bites technique

Large bites suturing technique of the abdominal wall during midline laparotomy

ACTIVE COMPARATOR

As control the conventional large bites technique (mass closure) was applied with bites widths of 1 cm and inter-suture spacing of 1 cm with the use of PDS plus ll 1-0 double loop suture material with a 48 mm needle.

Procedure: Conventional large bites closure

Interventions

Small bites technique PROCEDURE

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.

Small bites suturing technique of the abdominal wall during midline laparotomy

Conventional large bites closure PROCEDURE

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

Large bites suturing technique of the abdominal wall during midline laparotomy

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

In order to be eligible to participate in this study, a subject must meet the following criteria: * Available signed informed consent form for the original STITCH trial of the patients who are still alive. * Or if the patients has died, the medical records are reviewed. A potential subject who meets the following criteria will be excluded from participation in this study: \- Patients that on the original informed consent form of the STITCH trial, checked the box that they did not want to be approached for future follow-up studies.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Franciscus &Vlietland: collaborator
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• Rijnstate Hospital: collaborator
• Spaarne Gasthuis: collaborator
• Meander Medisch Centrum: collaborator
• Red Cross Hospital Beverwijk: collaborator

Study Sites (9)

Erasmus MC

Rotterdam, South Holland, 3015, Netherlands

RECRUITING

Meander Medical Center

Amersfoort, Netherlands

RECRUITING

Rijnstate ziekenhuis

Arnhem, Netherlands

RECRUITING

Red Cross Hospital

Beverwijk, Netherlands

RECRUITING

Groene Hart Ziekenhuis

Gouda, Netherlands

RECRUITING

Spaarne Gasthuis

Haarlem, Netherlands

RECRUITING

Franciscus Gasthuis & Vlietland

Rotterdam, Netherlands

RECRUITING

Prior Havenziekenhuis patients currently in the Erasmus MC

Rotterdam, Netherlands

RECRUITING

Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

RECRUITING

Related Links

• Original STITCH trial

MeSH Terms

Conditions

Incisional Hernia; Wound Infection; Pain; Pathological Conditions, Anatomical; Infections; Postoperative Complications; Pathologic Processes

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Pieter J Tanis

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rudolf van den Berg

CONTACT

0107043683; R.vandenBerg.4@Erasmusmc.nl

Sarah van Egmond

CONTACT

0107043683; S.vanEgmond@Franciscus.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors of previous radiological imaging and imaging created during our Long-term follow up will be blinded to the assigned randomization arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr. P.J. Tanis

Model Details: A Long-term follow-up with Outcome Assesor blinding of a parallel assigned double blinded (Participant, Investigator) Randomised Controlled trial

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: October 4, 2023
• Study Start: August 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (9)