LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

Operative Time Clinical Trial

Official title:

Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Ovarian Drilling: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03206892
• Other study ID #: LESS surgery AinShamsMH
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2019
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

laparoendoscopic single-site surgery is compared to conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure with less side effects

Description:

Laparoendoscopic single-site surgery; one of the most recent advances in the field of minimally invasive surgery, is the use of a single incision in the umbilicus for laparoscopic surgeries, is compared to the conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure without conversion to laparotomy or use of an additional port in the single site group. in addition to operative time, intra- and post- operative complications and cosmetic outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• PCOS according to Rotterdam Criteria (2 out of 3):

• polycystic ovaries (12 or more follicles in each ovary and/or increased ovarian volume >10 cm3).

• oligo- or an-ovulation.

• clinical and/or biochemical hyperandrogenisim. After exclusion of other aetiologies for irregular cycles.

• Indications of laparoscopic ovarian drilling:

• clomiphene citrate- resistance or failure: failure to conceive after 6 to 9 cycles.

• other indications for laparoscopy.

• before gonadotropin administration to decrease risk of OHSS and multiple pregnancy.

• before ART to decrease risk of severe OHSS in women who previously had canceled IVF cycles due to OHSS risk or who suffered from OHSS in a previous treatment.

Exclusion Criteria:

• previous 2 or more laparotomies.

• chronic pelvic pain, endometriosis or pelvic inflammatory diseases to avoid pelvic adhesions and bias in the quantification of postoperative pain.

• High BMI (>35kg/m2)

• do not possess a native umbilicus.

• advanced gynaecological surgeries or malignant disorders (TLH, ALVH, laparoscopic myomectomy).

• contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or Trendelnburg position.

Related Conditions & MeSH terms

• Cosmetic Outcome
• Intra- and Post- Operative Complications
• Operative Time
• Postoperative Complications
• Successful Surgical Procedure

Intervention

Device:
• laparoscopic ovarian drilling
laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women comparing LESS surgery to conventional multiport laparoscopy

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful surgical procedure	without conversion to laparotomy or the use of an additional port in the single-site group (number of ports).	1 hour (minutes)
Secondary	operative time	from trocar insertion to last skin stitch (minutes)	1 hour (minutes)
Secondary	intraoperative blood loss	amount of blood in the suction bottle (mL), drop in postoperative haemoglobin (g/dl)	24 hour after end of procedure
Secondary	intraoperative complications	blood transfusion (number of units), bowel, bladder or ureteric injuries	1 hour
Secondary	postoperative hospital stay	number of days	3 days
Secondary	postoperative pain	visual analogue scale (0-10 scale), number of postoperative analgesic ampules needed	1st day
Secondary	postoperative complications	hematoma, wound infection, ileus, UTI	1st week
Secondary	cosmetic outcome	scar image	day 1 and day 7