Assessing whether using a protective bag during minimally invasive surgery to remove ovarian tumours can prevent tumour spreading during surgery

Protective bag used in laparoscopic ovarian tumor enucleation prevents intraoperative tumor dissemination in pelvic and abdominal cavities: a prospective multicenter self-controlled clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41717941

Enrollment

Registered

2019-03-28

Start date

2019-12-01

Completion date

Unknown

Last updated

2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian tumor Cancer

Interventions

A total of 90 patients hospitalized for ovarian tumors who need laparoscopic surgery will be enrolled in this trial. All patients will undergo laparoscopic ovarian tumor enucleation with a protective

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Ovarian cysts persist or increase, and the diameter of cysts lasts more than 5 cm before and after menstruation. 2. Age of 18 to 50 years old.

Exclusion criteria

Exclusion criteria: 1. Severe heart, lung, liver, and kidney dysfunction. 2. The space is limited for the operation in the pelvic and abdominal cavities, and the mass obstructs the field of vision; pneumoperitoneum or puncture may cause tumor rupture. 3. Breastfeeding and pregnant women. 4. Patients suspected of having deep invasive endometriosis before operation. 5. Participation in other clinical trials.

Design outcomes

Primary

Measure	Time frame
Recurrence rate of ovarian tumors within 12 months after surgery.	—

Secondary

Measure	Time frame
1. Number of tumor cells in peritoneal flushing fluid before and after surgery 2. Difference of vaginal length before and 2, 6, and 12 months after surgery 3. Change of vaginal microecology before and 2 months after surgery: 3.1. Vaginal secretions will be smeared, dried, fixed, and then receive Gram’s staining. Vaginal flora will be examined under the oil immersion lens, including dominant bacteria, microbial concentration, microbial diversity, trichomonas, and fungi. 4. Sexual function will be measured using the Female Sexual Function Index before and 6 and 12 months after surgery. 5. Indications for cesarean section will be recorded if the patient undergoes cesarean section within 12 months after operation. 6. Integrity of posterior vaginal wall after spontaneous delivery will be recorded if the patient has spontaneous delivery within 12 months after operation.	—

Measure

Time frame

1. Number of tumor cells in peritoneal flushing fluid before and after surgery 2. Difference of vaginal length before and 2, 6, and 12 months after surgery 3. Change of vaginal microecology before and 2 months after surgery: 3.1. Vaginal secretions will be smeared, dried, fixed, and then receive Gram’s staining. Vaginal flora will be examined under the oil immersion lens, including dominant bacteria, microbial concentration, microbial diversity, trichomonas, and fungi. 4. Sexual function will be measured using the Female Sexual Function Index before and 6 and 12 months after surgery. 5. Indications for cesarean section will be recorded if the patient undergoes cesarean section within 12 months after operation. 6. Integrity of posterior vaginal wall after spontaneous delivery will be recorded if the patient has spontaneous delivery within 12 months after operation.

—

Countries

China

Contacts

Public ContactJumin Niu

niujumin@163.com+86-13591686272

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026