Prolapse PelvicLAPCALLNCT04560543
Prophylactic Laparoscopic Suspension After McCall
A study testing McCall suture and Standard cuff closure in people with Prolapse Pelvic, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolapse Pelvic
- What is being tested?
- McCall suture and Standard cuff closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 May 2021to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LSC simple hysterectomy,
- Neg. SS test if premenopausal
- >18j,
- Consent to participate in the study
- Understanding of the German language
Who cannot join
- Prolapse as indication for surgery
- Known or suspected non-compliance
- Additional incontinence procedures
- Patients with deep infiltrating endometriosis
- Irradiation pre- or postoperative
- Pregnancy and lactation.
- Conversion from laparoscopy to laparotomy
- Inability to understand the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsfrauenklink Inselspital
Bern, 3010
About this study
Official title: Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome
There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results.
The aim is to test the effectiveness of the laparoscopic McCall suture compared to usual vaginal cuff closure in a randomized controlled double-blinded trial.
Read the detailed description
182 patients will be enrolled in the study. We randomize the patient before surgery and information about the procedure will be transmitted to the theatre in a sealed envelope. The surgeon will open the envelope just before surgery. For randomization we apply a 1:1 allocation (standard vaginal cuff closure VS standard vaginal cuff closure with McCall sutures). The McCall suture is standardized: we apply a purse-string suture including both USL and the peritoneum.
Follow-up visits measuring POP-Q are planned after 6 weeks and yearly until 5 years.
- Conditions
- Prolapse Pelvic
- Being tested
- McCall suture, Standard cuff closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McCall sutureProcedure or surgery
Also called Uterosacral Ligament Suspension
Laparoscopic suture including the uterosacral ligaments and the peritoneum
Standard cuff closureProcedure or surgery
Standard laparoscopic barbed suture of the vaginal cuff
| Study group | Role | What they receive |
|---|---|---|
| McCall suture | Experimental | Uterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent. Receives: Procedure: McCall suture |
| standard cuff closure | Sham comparator | Uterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far) Receives: Procedure: Standard cuff closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolapse of the apical compartment. Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q) Depending on vaginal length, it could vary between +10 and -10cm.
Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q), ranges from -10 (low) to +10 (high), better outcome with higher score endpoint is the prolapse of the apical compartment (point D in the POP-Q score, vaginal dome in relation to the hymen) after 5 years.
Point D is a value measured in centimeters. Depending on vaginal length, it could vary between +10 and -10cm. Reference point of all measurements is the hymen.
Measured: 5 years
Secondary outcomes (1)
Sexual function
Quantification by the Female Sexual Function Index, Score 0 - 5, better outcome with higher score
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start15 May 2021
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse PelvicStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel D Mueller, Prof., Study director, Department of Gynaecology, University Hospital, Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560543
- Sponsor's protocol ID
- 2020-01046
- Acronym
- LAPCALL
- Status last verified
- May 2026
- First submitted
- 17 Sep 2020
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome
- ClinicalTrials.gov ID
- NCT04560543
- Acronym / sponsor ID
- LAPCALL / 2020-01046
- Conditions
- Prolapse Pelvic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results.
The aim is to test the effectiveness of the laparoscopic McCall suture compared to usual vaginal cuff closure in a randomized controlled double-blinded trial.
Detailed description
182 patients will be enrolled in the study. We randomize the patient before surgery and information about the procedure will be transmitted to the theatre in a sealed envelope. The surgeon will open the envelope just before surgery. For randomization we apply a 1:1 allocation (standard vaginal cuff closure VS standard vaginal cuff closure with McCall sutures). The McCall suture is standardized: we apply a purse-string suture including both USL and the peritoneum.
Follow-up visits measuring POP-Q are planned after 6 weeks and yearly until 5 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McCall suture | Experimental | Procedure: McCall sutureUterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent. |
| standard cuff closure | Sham comparator | Procedure: Standard cuff closureUterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- LSC simple hysterectomy,
- Neg. SS test if premenopausal
- >18j,
- Consent to participate in the study
- Understanding of the German language
Key exclusion criteria (8 listed)
- Prolapse as indication for surgery
- Known or suspected non-compliance
- Additional incontinence procedures
- Patients with deep infiltrating endometriosis
- Irradiation pre- or postoperative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McCall sutureAlso: Uterosacral Ligament SuspensionLaparoscopic suture including the uterosacral ligaments and the peritoneum | Procedure or surgery | McCall suture |
| Standard cuff closureStandard laparoscopic barbed suture of the vaginal cuff | Procedure or surgery | standard cuff closure |
Primary outcome
Prolapse of the apical compartment. Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q) Depending on vaginal length, it could vary between +10 and -10cm.
Time frame: 5 years
Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q), ranges from -10 (low) to +10 (high), better outcome with higher score endpoint is the prolapse of the apical compartment (point D in the POP-Q score, vaginal dome in relation to the hymen) after 5 years. Point D is a value measured in centimeters. Depending on vaginal length, it could vary between +10 and -10cm. Reference point of all measurements is the hymen.
1 secondary outcome
Sexual function
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
Related trials for Prolapse Pelvic
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michel D Mueller, Prof. study director
Department of Gynaecology, University Hospital, Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McCall suture and Standard cuff closure in people with Prolapse Pelvic, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Höhn, MD (0316321010 ext. 0316321010, diana.hoehn@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolapse of the apical compartment. Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q) Depending on vaginal length, it could vary between +10 and -10cm. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.