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Mesh vs. muscle flap: which rebuilds pelvic floor better after cancer surgery?

NCT ID NCT01347697

Disease control Sponsor: Umeå University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two methods to repair the pelvic floor after removing the rectum for advanced rectal cancer. One method uses a biological mesh made from pig collagen, the other uses a flap of muscle from the buttock. The goal was to see which approach leads to better physical function six months after surgery. The trial involved 91 adults and was completed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
porcine acellular dermal collagen implant (biological mesh)
What this could lead to
If the biological mesh works better, it could offer a simpler, less painful recovery for patients after rectal cancer surgery.
What could go wrong
This is a small, completed trial with only 91 participants, so results may not apply to everyone. The mesh might not improve physical performance as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

91 people

The number who actually took part.

Started

Sep 2011

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult (18 years or older) rectal cancer patients where wide resection of pelvic floor muscles together with rectum and anal canal have made reconstruction of pelvic floor necessary i.e. primary suture of pelvic floor in the midline is not possible. Resection of coccyx is optional. Exclusion Criteria: * Age less than 18 years * Very large resections including partial resection of sacrum and patients considered for bilateral flap reconstruction * Large concomitant resection of vaginal wall where total (vaginal) wound closure is not an option * Expected survival less than one year at operation * Patient do not sign informed consent document

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Defect of floor of lesser pelvis Rectal cancer

Contacts and locations

Locations

  • Karolinska University Hospital, Solna

    Stockholm, 171 76, Sweden

  • Oulu University Hospital

    Oulu, Finland

  • Skåne Universtiy Hospital

    Malmö, 20502, Sweden

  • Sunderby County Hospital

    Luleå, 971 80, Sweden

  • Umeå University Hospital, Department of Surgical and Perioperative Sciences

    Umeå, 901 85, Sweden

  • Uppsala University Hospital

    Uppsala, 751 85, Sweden

  • Västmanlands Sjukhus Västerås

    Västerås, 72189, Sweden

  • Östersund Hospital

    Östersund, 831 83, Sweden

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