--- title: Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer nct_id: NCT00003267 overall_status: COMPLETED phase: PHASE3 sponsor: European Organisation for Research and Treatment of Cancer - EORTC study_type: INTERVENTIONAL primary_condition: Cervical Cancer countries: Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00003267.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00003267" ct_last_update_post_date: 2012-07-11 last_seen_at: "2026-05-12T07:19:05.485Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer **Official Title:** A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection (RHND) **NCT ID:** [NCT00003267](https://clinicaltrials.gov/study/NCT00003267) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 214 - **Lead Sponsor:** European Organisation for Research and Treatment of Cancer - EORTC - **Conditions:** Cervical Cancer, Endometrial Cancer, Infection, Perioperative/Postoperative Complications, Vaginal Cancer - **Start Date:** 1998-02 - **CT.gov Last Update:** 2012-07-11 ## Brief Summary RATIONALE: The use of pelvic drains may help to prevent complications following radical hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains during surgery is more effective than receiving no pelvic drains during surgery in patients with uterine, cervical, or vaginal cancer. PURPOSE: Randomized phase III trial to determine if the use of pelvic drains following radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with uterine, cervical, or vaginal cancer. ## Detailed Description OBJECTIVES: I. Evaluate postoperative complications associated with the use or omission of pelvic drains following radical hysterectomy and node dissection that includes suturing of the vaginal cuff and no peritonealization. OUTLINE: This is a randomized, two-arm study. All patients receive radical hysterectomy (Rutledge-Piver II-III type) and pelvic lymphadenectomy, without pelvic and parietal peritonealization, with suturing of the vaginal cuff and closure of fascia and cutaneous layers; lumboaortic node dissection is optional. Patients are randomized during surgery to one of two arms: those on arm I receive pelvic drains and those on arm II do not. Those in arm I have drains applied in the pelvis, and lymph is collected by vaginal and/or transabdominal drains located in both retroperitoneal fossa. Drains are removed when the loss is less than 50 mL in 24 hours. Patients in both arms are followed at 2-3 months and 12 months after surgery. PROJECTED ACCRUAL: 214 patients will be accrued for this study within 2 years. ## Eligibility - **Sex:** ALL - **Healthy Volunteers:** No ``` DISEASE CHARACTERISTICS: Histologically proven cervical, vaginal, or endometrial carcinoma for which abdominal radical hysterectomy (Rutledge-Piver II or III type) and pelvic node dissection is indicated The following are excluded: Extensive intraoperative retroperitoneal blood loss (more than 3000 mL) Excessive postsurgical hemorrhage or oozing of the wound area requiring postoperative drainage Concurrent urinary or bowel injury/deviation or surgical procedures for urinary incontinence (Burch etc.) Application of prophylactic abdominal mesh for subsequent radiotherapy PATIENT CHARACTERISTICS: Age: Not specified Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics ``` ## Interventions - **infection prophylaxis and management** (PROCEDURE) - **management of therapy complications** (PROCEDURE) - **surgical procedure** (PROCEDURE) ## Locations (18) - Kaiser Franz Josef Hospital, Vienna (Wien), Austria - Universitair Ziekenhuis Antwerpen, Edegem, Belgium - U.Z. Gasthuisberg, Leuven, Belgium - Institut Gustave Roussy, Villejuif, France - University Medical Center, Freiburg im Breisgau, Germany - Universita di Brescia, Brescia, Italy - Instituto Scientifico H.S. Raffaele, Milano (Milan), Italy - Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano (Milan), Italy - Azienda Ospedaliera Di Parma, Parma, Italy - University and I.R.C.C.S. Policlinico San Matteo, Pavia, Italy - Ospedale di Circolo e Fondazione Macchi, Varese, Italy - Ospedale Civile, Voghera (PV), Italy - Antoni van Leeuwenhoekhuis, Amsterdam, Netherlands - Medisch Spectrum Twente, Enschede, Netherlands - Leiden University Medical Center, Leiden, Netherlands - Academisch Ziekenhuis Utrecht, Utrecht, Netherlands - Hospitais da Universidade de Coimbra (HUC), Coimbra, Portugal - Instituto Valenciano De Oncologia, Valencia, Spain ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.kaiser franz josef hospital|vienna (wien)||austria` — added _(2026-05-12)_ - `locations.universitair ziekenhuis antwerpen|edegem||belgium` — added _(2026-05-12)_ - `locations.u.z. gasthuisberg|leuven||belgium` — added _(2026-05-12)_ - `locations.institut gustave roussy|villejuif||france` — added _(2026-05-12)_ - `locations.university medical center|freiburg im breisgau||germany` — added _(2026-05-12)_ - `locations.universita di brescia|brescia||italy` — added _(2026-05-12)_ - `locations.instituto scientifico h.s. raffaele|milano (milan)||italy` — added _(2026-05-12)_ - `locations.istituto nazionale per lo studio e la cura dei tumori|milano (milan)||italy` — added _(2026-05-12)_ - `locations.azienda ospedaliera di parma|parma||italy` — added _(2026-05-12)_ - `locations.university and i.r.c.c.s. policlinico san matteo|pavia||italy` — added _(2026-05-12)_ - `locations.ospedale di circolo e fondazione macchi|varese||italy` — added _(2026-05-12)_ - `locations.ospedale civile|voghera (pv)||italy` — added _(2026-05-12)_ - `locations.antoni van leeuwenhoekhuis|amsterdam||netherlands` — added _(2026-05-12)_ - `locations.medisch spectrum twente|enschede||netherlands` — added _(2026-05-12)_ - `locations.leiden university medical center|leiden||netherlands` — added _(2026-05-12)_ - `locations.academisch ziekenhuis utrecht|utrecht||netherlands` — added _(2026-05-12)_ - `locations.hospitais da universidade de coimbra (huc)|coimbra||portugal` — added _(2026-05-12)_ - `locations.instituto valenciano de oncologia|valencia||spain` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00003267.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00003267* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*