Prospective Randomized Clinical Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Endoscopic Surgery (notes) (nct00835250)

José F Noguera, PhD MD, Angel Cuadrado, PhD MD, Juan C García, MD, Rafael Morales, MD, José M Olea, MD. Hospital Son Llàtzer, IUNICS, IDMQ

PURPOSE.

The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).

DESIGN.

Study Type: Interventional
Study Design:
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Outcome Measures:
Parietal complications after surgery (infection and hernia) [ Time Frame: One year ].

Secondary Outcome Measures:
Surgical pain. General complications. Patient’s preferences. [ Time Frame: One year ]

METHODS.

Prospective randomized clinical series of 60 female patients with gallstones that underwent endoscopic surgery, 20 of them operated with conventional laparoscopic approach, 20 by transumbilical endoscopic approach and 20 of them by transvaginal endoscopic approach. Variables as surgical wound infection, urinary tract infection, evisceration, hernia, mortality and other complications will be analyzed.

Eligibility
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:age over 18 and under 65
symptomatic cholelithiasis with an indication for performing laparoscopic surgery
absence of any gynecological condition that could complicate the procedure (pelvic inflammatory disease or endometriosis)
perforated hymen
agreement on the patient’s part not to use the vagina for two weeks after the surgery
signed specific informed consent upon providing specific information about the new surgical approach.

Exclusion Criteria:age under 18 or over 65
unperforated hymen
presence of illness or condition with an increased risk of pelvic damage with transvaginal approach.

RESULTS.

Surgical Complications. There were no significant differences.

Conversion to laparoscopic or open surgery. 1case in transumbilical group, converted to laparoscopy by difficulty in handling the endoscope. No significant differences.

Enlargement of the entry port. In laparoscopic group 66.7% needed an enlargement, 45% in transumbilical group, while in transvaginal group expansion was not required in any case. Enlargement has not been associated with wound complications.

Postoperative pain. There were no differences in postoperative pain quantified by VAS scores. (Treatment: Dipyrone 1 g ev x 6h).

Dyspareunia. The incidence of dyspareunia was nil (one year follow-up)

Hospital stay. There were no differences between groups. Hospital stay was 24 hours for 58 patients, two patients required two days. The protocol required one-day-stay.

Cost of the procedure. Cost was higher for groups that used the endoscope, because of the cost of the flexible endoscope. From case 30 onwards, the cost is the same for the procedures.

Surgical time. Significant differences between laparoscopy (47,04 minutes) and the other two techniques (transumbilical 59,80 and transvaginal 64,85). (Mann-Whitney test, p <0.001).

CONCLUSIONS.

Transvaginal approach with flexible endoscope is not inferior in efficacy and safety to conventional laparoscopy.
Transumbilical approach with the flexible endoscope is as effective and safe as transvaginal one and it’s is promising for the future (Flexible Single Incision Surgery).