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NCT07189780Toborzás még nem indult

Comparison of Different Surgical Approaches in Female Rectal Cancer.

Impact of Two Different Anterior Rectal Wall Mobilization Techniques on Postoperative Outcomes in Female Patients With Mid-low Rectal Cancer: a Multicenter, Prospective, Randomized Controlled Clinical Trial.

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 24. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még

Rövid összefoglaló (regiszter, angolul)

Mid-to-low rectal cancer exhibits an extremely high incidence rate in China. Currently, the primary treatment approach for mid-to-low rectal cancer remains surgical intervention, with total mesorectal excision (TME) being the mainstream procedure. In male patients, Heald, Chi Pan , Wei Hongbo , and others have proposed different dissection techniques for the anterior rectal wall. Partial or complete preservation of Denonvilliers Fascia (DVF) during conventional TME (as proposed by Heald) has been shown to significantly reduce intraoperative bleeding and improve postoperative urodynamic function, urinary continence, and sexual function . However, these studies focused exclusively on male patients and did not include female subjects. In our previous research, we proposed that females do not possess an anatomical structure equivalent to the male DVF. Furthermore, compared to entering the dissection plane by incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection, initiating the peritoneal incision precisely at the lowest point of the peritoneal reflection better ensures the integrity of the mesorectum and vaginal structures, reduces intraoperative bleeding, provides a more favorable operative field, and avoids damage to physiological structures while ensuring complete tumor resection, thereby promoting postoperative recovery. Thus, we concluded that this plane represents the optimal surgical dissection plane for the anterior rectal wall during TME in female patients with mid-to-low rectal cancer without anterior wall invasion. Since our prior study combined anatomical and clinical retrospective research, we have initiated a prospective multicenter randomized controlled trial to further validate these clinical findings. This study aims to demonstrate that entering the dissection plane at the lowest point of the peritoneal reflection during mid-to-low rectal cancer surgery improves prognosis in female patients, providing high-level evidence-based medical support for the adoption of this technique and establishing the optimal surgical approach for female rectal cancer patients.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
200 (tervezett)
Első benyújtás
2025. szept. 17.
Kezdés
2025. okt. 1.
Elsődleges befejezés
2027. aug. 31.
Fő szponzor
First Affiliated Hospital of Wenzhou Medical University
NCT-szám
NCT07189780

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 200
  • 2025. okt. 1. és az elsődleges befejezés (2027. aug. 31.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Intraoperative findings of tumor invasion into adjacent organs necessitating multivisceral resection or palliative resection.
  • Previous history of anorectal or rectal surgery. 6Preoperative magnetic resonance imaging (MRI) indicating invasion of the anterior rectal wall.

Más betegség

  • Presence of severe pre-existing comorbidities (e.g., significant hepatic, renal, cardiac, pulmonary, or coagulation dysfunction).
  • History of malignancy in other organs.
  • Patients requiring emergency surgery due to conditions such as acute perforation or obstruction.

Kiket keres a vizsgálat

  • Pathologically confirmed rectal adenocarcinoma.
  • Female patients scheduled to undergo laparoscopic total mesorectal excision (TME).
  • Body mass index (BMI) ≤ 30 kg/m².
  • Tumors with the distal margin located ≤ 10 cm from the anal verge.
  • Absence of distant metastases (e.g., to the liver, lungs, or other organs).

Nem: csak nők · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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