Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003267
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine Cervical or Vaginal Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection RHND
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-55962 | None | None | None |