Clinical trial · Interventional
Multicenter Study on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision
A Prospective, Multicenter Clinical Study of Preservative Effect on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision for Male Rectal Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Urinary and sexual dysfunctions are among the most common complications in rectal cancer surgery. The aim of this study was to investigate the protective effect of laparoscopic functional total mesorectum excision (FTME) on urinary and sexual function in male patients with mid-low rectal cancer. This is a prospective, single-arm, multicenter, uncontrolled, clinical study in 88 eligible subjects with mid-low rectal cancer. After informed consent, eligible patients will be performed laparoscopic FTME surgery. Patients' demographic, operative detail, postoperative outcomes and follow-up will be recorded prospectively.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic FTME surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FTME group
- description
- Participants will undergo laparoscopic FTME surgery.
- interventionNames
- Procedure: Laparoscopic FTME surgery
Primary outcomes (2)
- measure
- Incidence of sexual dysfunction
- timeFrame
- 6 months
- description
- The 5-item version of the International Index of Erectile Function (IIEF-5) and ejaculation function are used to assess sexual function. the IIEF-5 total score ranged from 1 to 25, with a lower score indicating more severe erectile dysfunction, male sexual dysfunction was defined as the IIEF-5 score ≤11points. Ejaculation function was classified as: Grade I, normal ejaculation; Grade II: retrograde ejaculation; Grade III: anejaculation, and ejaculation dysfunction was identified as ejaculation function of grade II/III.
- measure
- Incidence of urinary dysfunction
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male, 18-70 years of age, informed consent; 2. Tumors from anal edge 6 \~ 12 cm (measured by rigid proctoscope); 3. Rectal cancer confirmed pathologically by endoscopic biopsy; 4. Preoperative cT1-3aN0M0 stage (ESMO, 2013); 5. Ro resection is expected; 6. Normal urinary function, normal erection function and ejaculation function grading as I level; Exclusion Criteria: 1. History of abdominal and pelvic major surgery; 2. Emergency surgery is needed due to the complication (bleeding, obstruction, or perforation) caused by rectal cancer; 3. Pelvic or distant metastasis; 4. Neoadjuvant radiotherapy or chemoradiotherapy; 5. No sexual life;
References
Publications (2)
- BACKGROUNDLi K, He X, Tong S, Zheng Y. Nerve plane: An optimal surgical plane for laparoscopic rectal cancer surgery? Med Hypotheses. 2021 Sep;154:110657. doi: 10.1016/j.mehy.2021.110657. Epub 2021 Aug 5. PMID 34388537
- BACKGROUNDLi K, He X, Zheng Y. An Optimal Surgical Plane for Laparoscopic Functional Total Mesorectal Excision in Rectal Cancer. J Gastrointest Surg. 2021 Oct;25(10):2726-2727. doi: 10.1007/s11605-021-05035-9. Epub 2021 Jun 9. PMID 34109532