Clinical trial · Interventional
Tissue Removal During Hysterectomy: The Effect of Vaginal Versus Abdominal Morcellation on Surgical Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): investigator left the institution- no plan on having another PI take over
Summary
Brief summary (as posted)
In this study the investigators will perform a randomized trial to compare the surgical outcomes of vaginal versus abdominal morcellation of the uterus during hysterectomy. In minimally invasive gynecologic surgery small incisions are made in the abdomen and pelvis so that a hysterectomy can be performed by laparoscopy. The challenge is then to remove the uterus, which may be quite large, through these small incisions. One option is to morcellate the uterus and remove the tissue through either a small abdominal incision or an incision in the vagina. When an organ is morcellated it is cut into smaller pieces so that it can be removed, section by section, through a small incision. The investigators will compare these two methods of tissue removal to see whether one results in better surgical outcomes or increased intra-operative or post-operative complications. The primary outcome will be the time it takes to perform the surgery (operative time). Secondary surgical outcomes that will be studied include the amount of blood lost during surgery, post-operative complications, and readmission to the hospital.
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 |
|---|---|---|---|
| Fibroids | Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| abdominal morcellation | Procedure | — | UNRESOLVED |
| vaginal morcellation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- abdominal morcellation
- description
- Women randomized to this group will undergo abdominal morcellation.
- interventionNames
- Procedure: abdominal morcellation
- type
- ACTIVE_COMPARATOR
- label
- vaginal morcellation
- description
- Women randomized to this group will undergo vaginal morcellation.
- interventionNames
- Procedure: vaginal morcellation
Primary outcomes (1)
- measure
- Total operative time
- timeFrame
- Perioperative
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Hysterectomy planned for a benign gynecologic reason * Patient is scheduled to have surgery with one of the minimally invasive gynecologic surgeons at George Washington University Hospital. (Dr. Moawad, Dr. Marfori, or Dr. Vargas) * Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or a total laparoscopic hysterectomy (TLH) * Patient is capable of informed consent * Patient must be between 18 and 65 years of age * Uterus greater than 12 centimeters in height and 4 centimeters in width or 12 weeks in size Exclusion Criteria: * Hysterectomy is indicated for malignancy * Procedure is anything other than RA-TLH or TLH * Surgeon is not one of hte minimally invasive surgeons at GWUH * Surgery is scheduled for a hospital other than GWUH * Patient does not meet the age requirements. * Patient is not capable of informed consent * Uterus is less than 12 cm in heightand 4 cm in width
References
Publications (0)
Data not yet available