Evidence map›Paper›PMID 38877450›Full record

Trial reportBMC surgery2024

Early safety and efficiency outcomes of a novel interdisciplinary laparoscopic resection rectopexy combined with sacrocolpopexy for women with obstructive defecation syndrome and pelvic organ prolapse: a single center study.

Claudia Rudroff, Joshy Madukkakuzhy, Alberto Vega Hernandez, Jakob Otten, Christoph Ulrici, Leonidas Karapanos, Sebastian Ludwig

2 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in BMC surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05910021 completednot on this map

Early Safety and Efficiency of Interdisciplinary Laparoscopic Resection Rectopexy Combined With Sacrocolpopexy for Women With Obstructive Defecation Syndrome and Pelvic Organ Prolapse

TypeobservationalSponsorEvangelisches Klinikum Köln Weyertal gGmbHRan2020 to 2024Enrolled35ConditionsConstipation by Outlet Obstruction, Pelvic Organ Prolapse, Urinary Incontinence
NCT06502184 completednot on this map

Functional and Mental Outcomes After Interdisciplinary Surgery for Patients With Obstructive Defecation Syndrome (ODS)

TypeobservationalSponsorEvangelisches Klinikum Köln Weyertal gGmbHRan2020 to 2023Enrolled140ConditionsSurgery, Obstructive Defecation Syndrome, Mental Health Issue, Depression/Anxiety
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Observational
  5. Observational
  6. Article
  7. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Claudia RudroffDepartment of Visceral Surgery and Functional Surgery of the Lower Gastrointestinal Tract (UGI), Clinic for General and Visceral Surgery, Evangelisches Klinikum Köln Weyertal GmbH, Academic Hospital of the University of Cologne, Weyertal 76, Cologne, 50931, Germany. claudia@rudroff.com.
Joshy MadukkakuzhyDepartment of Visceral Surgery and Functional Surgery of the Lower Gastrointestinal Tract (UGI), Clinic for General and Visceral Surgery, Evangelisches Klinikum Köln Weyertal GmbH, Academic Hospital of the University of Cologne, Weyertal 76, Cologne, 50931, Germany.
Alberto Vega HernandezDepartment of Visceral Surgery and Functional Surgery of the Lower Gastrointestinal Tract (UGI), Clinic for General and Visceral Surgery, Evangelisches Klinikum Köln Weyertal GmbH, Academic Hospital of the University of Cologne, Weyertal 76, Cologne, 50931, Germany.
Jakob OttenDepartment of Visceral Surgery and Functional Surgery of the Lower Gastrointestinal Tract (UGI), Clinic for General and Visceral Surgery, Evangelisches Klinikum Köln Weyertal GmbH, Academic Hospital of the University of Cologne, Weyertal 76, Cologne, 50931, Germany.
Christoph UlriciDepartment of Visceral Surgery and Functional Surgery of the Lower Gastrointestinal Tract (UGI), Clinic for General and Visceral Surgery, Evangelisches Klinikum Köln Weyertal GmbH, Academic Hospital of the University of Cologne, Weyertal 76, Cologne, 50931, Germany.
Leonidas KarapanosDepartment of Urology, Division of Neurourology, University Hospital of Cologne and Medical Faculty Cologne, 50931, Cologne, Germany.
Sebastian LudwigDepartment of Obstetrics and Gynecology, Division of Urogynecology and Pelvic Reconstructive Surgery, University Hospital of Cologne and Medical Faculty Cologne, 50931, Cologne, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundObstructive defecation syndrome (ODS) defines a disturbed defecation process frequently associated with pelvic organ prolapse (POP) in women that substantially compromises quality of life. Conservative management offers limited relief and a surgical intervention may be required. This is characterized by individual approaches. AIM OF THE STUDY: This retrospective single center study evaluated the surgical and clinical short-term outcome of a novel interdisciplinary laparoscopic resection rectopexy (L-RRP) with mesh- sacrocolpopexy (L-SCP) for women suffering from ODS and POP.

methodsThe study participants underwent surgery in an interdisciplinary laparoscopic approach. Safety was the primary endpoint, assessed via postoperative morbidity classified by Clavien-Dindo scale. Secondary outcomes included evaluation of bowel function, fecal and urinary incontinence and pelvic organ prolapse status at 12 months follow-up. Additionally, a biological mesh (BM) was offered to women, who asked for an alternative to synthetic mesh material (SM).

resultsOf the 44 consecutive patients requiring surgery for ODS and POP, 36 patients underwent the interdisciplinary surgical approach; 28 patients with SM and 8 patients with BM. In total 5 complications occurred, four of them were classified as minor. One minor complication was observed in the BM group. One anastomotic leakage occurred in the SM group. The two ODS scores, the bowel dysfunction score, and the incontinence score improved significantly (p = 0.006, p = 0.003, p < 0.001, and p = 0.0035, respectively). Pelvic floor anatomy was fully restored (POP-Q 0) for 29 (80%) patients after surgery. 17 patients (47%) suffered from urinary incontinence before surgery, which was restored in 13 patients (76.5%).

conclusionsThe interdisciplinary approach with L-RRP and L-SCP and the use of a BM in a small subgroup were technically feasible, safe, and effective in this single center setting. The study's retrospective design, the small sample size and the lack of comparators limit the generalizability of the findings requiring future randomized trials.

trial registrationRetrospectively registered at clinicaltrials.gov, trial number NCT05910021, date of registration 06/10/2023.

Indexed as

LaparoscopyPelvic Organ ProlapseSurgical MeshAgedConstipationDefecationFemaleGynecologic Surgical ProceduresHumansMiddle AgedPostoperative ComplicationsRectumRetrospective StudiesSyndromeTreatment OutcomeVaginaBiological meshObstructed defecation syndromePelvic organ prolapseResection rectopexySacrocolpopexySynthetic mesh

Identifiers

PMID38877450
PMCPMC11177501

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.