NCT04564677

Brief Summary

The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

4.8 years

First QC Date

September 3, 2020

Last Update Submit

October 9, 2023

Conditions

RectoceleEnteroceleRectal Prolapse

Outcome Measures

Primary Outcomes (16)

  • Procedural efficacy - Number of participants with (serious) adverse events

    Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo

    During procedure

  • Procedural efficacy - Conversion rate to laparotomy during the index procedure

    Number of conversions to laparotomy during the index procedure

    During procedure

  • Procedural efficacy - Number of participants with (serious) adverse events

    Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo

    At discharge (assessed up to 1 week)

  • Procedural efficacy - Number of re-interventions

    Number of re-interventions

    At discharge (assessed up to 1 week)

  • Procedural efficacy - Number of participants with (serious) adverse events

    Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo

    Follow-up 1: 6 - 10 weeks after the procedure

  • Procedural efficacy - Number of re-interventions

    Number of re-interventions

    Follow-up 1: 6 - 10 weeks after the procedure

  • Procedural efficacy - Number of post-operative recurrences

    Number of post-operative recurrences

    Follow-up 1: 6 - 10 weeks after the procedure

  • Procedural efficacy - Number of participants with (serious) adverse events

    Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo

    Follow-up 2: 12 months after the procedure

  • Procedural efficacy - Number of re-interventions

    Number of re-interventions

    Follow-up 2: 12 months after the procedure

  • Procedural efficacy - Number of post-operative recurrences

    Number of post-operative recurrences

    Follow-up 2: 12 months after the procedure

  • Procedural efficacy - Number of participants with (serious) adverse events

    Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo

    Follow-up 3: 24 months after the procedure

  • Procedural efficacy - Number of re-interventions

    Number of re-interventions

    Follow-up 3: 24 months after procedure

  • Procedural efficacy - Number of post-operative recurrences

    Number of post-operative recurrences

    Follow-up 3: 24 months after the procedure

  • Procedural efficacy - Number of participants with (serious) adverse events

    Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo

    Follow-up 4: 36 months after the procedure

  • Procedural efficacy - Number of re-interventions

    Number of re-interventions

    Follow-up 4: 36 months after the procedure

  • Procedural efficacy - Number of post-operative recurrences

    Number of post-operative recurrences

    Follow-up 4: 36 months after the procedure

Secondary Outcomes (25)

  • Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS)

    At baseline

  • Pre-operative vaginal pain by means of the Visual Analogue Scale (VAS)

    At baseline

  • Functional score - Obstructive Defecation Syndrome (ODS) score

    At baseline

  • Functional score - Cleveland Clinical Incontinence Score (CCIS)

    At baseline

  • Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)

    At baseline

  • +20 more secondary outcomes

Study Arms (1)

Patients eligible for laparoscopic ventral mesh rectopexy

Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR)

Device: Ifabond (Péters surgical)

Interventions

Ifabond (Péters surgical)DEVICE

Ifabond (Péters surgical) is a CE-marked synthetic surgical glue for internal and external use. The glue is non-toxic, biocompatible and biodegradable. It is commercially available and can be used for mesh fixation, as tissue adhesive, for sealing of sutured tissue and for hemostasis.

Patients eligible for laparoscopic ventral mesh rectopexy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy.

You may qualify if:

  • Female patients.
  • Patient ≥ 18 years of age at study entry.
  • Patient and investigator signed and dated the informed consent form prior to the index-procedure.
  • Patient with primary rectal prolapse (grades I to V according to the Oxford scale), rectocele and/or enterocele.

You may not qualify if:

  • Patient is unable / unwilling to provide informed consent.
  • Patient with recurrent rectal prolapse, rectocele and/or enterocele.
  • Patient is unable to comply with the study protocol or proposed follow-up visits.
  • Patient has a contra-indication for laparoscopic ventral mesh rectopexy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg (ZOL)

Genk, Belgium

RECRUITING

MeSH Terms

Conditions

RectoceleHerniaRectal Prolapse

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPelvic Organ ProlapseProlapse

Study Officials

  • Anne Dams, MD

    Ziekenhuis Oost-Limburg (ZOL)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie De Munter, PhD

CONTACT

+32 (0)11 28 69 48stephanie.de.munter@archerresearch.eu

Anne Dams, MD

CONTACT

+32 (0)89 32 60 20anne.dams@zol.be

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 25, 2020

Study Start

February 8, 2021

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)