European Journal of Obstetrics & Gynecology and Reproductive Biology
European Journal of Obstetrics & Gynecology and Reproductive Biology
European Journal of Obstetrics & Gynecology and Reproductive Biology
A R T I C L E I N F O A B S T R A C T
Article history: Objectives: To assess the effect of monopolar coagulation vs cut mode during colpotomy at total
Received 18 October 2018 laparoscopic hysterectomy on vaginal cuff dehiscence.
Received in revised form 17 December 2018 Study design: We conducted this randomized controlled trial at a university hospital’s department of
Accepted 23 December 2018
obstetrics and gynecology from September 2016 through January 2018. Enrolled women were
Available online xxx
randomized 1:1 to monopolar coagulation or cut modes during colpotomy. We followed up 100
participants in the coagulation arm and 99 in the cut arm for ongoing data collection for 12 weeks after
Keywords:
surgery. Exclusion criteria were suspicion of pregnancy, previous radiation therapy, uterine size
Coagulation
Cut
exceeding 20 weeks’ gestation, contraindication for high intraabdominal pressure, clinical advanced
Monopolar energy stage malignant disease, and conversion to laparotomy before completion of colpotomy. Differences
Total laparoscopic hysterectomy between groups for categorical variables were analyzed by chi-square test and the comparisons of
Vaginal cuff dehiscence continuous variables between groups were analyzed by Student’s t-test
Results: The study groups were comparable regarding demographics and perioperative parameters. The
rate of vaginal cuff dehiscence in coagulation group (1%) was similar to that of cut group (0%) (p = 0.995).
The other vaginal cuff related complication rates were also similar.
Conclusion: Monopolar coagulation and cut modes during colpotomy at total laparoscopic hysterectomy
have similar vaginal cuff dehiscence rates and both energy modes seem acceptable for colpotomy.
© 2019 Published by Elsevier B.V.
https://doi.org/10.1016/j.ejogrb.2018.12.034
0301-2115/© 2019 Published by Elsevier B.V.
S. Taşkın et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 234 (2019) 38–42 39
rates of VCD after TLH [2,8]. However, there is no exact data to laparoscopic bipolar forceps was used to stop brisk arterial
prove whether using energy or mode of energy increase the risk of bleeding from the vaginal cuff. The uterus was removed vaginally
VCD. Our hypothesis was that using cut or coagulation currents for in all of the operations. If the uterus was too big to remove vaginal
colpotomy during TLH are not associated with increased risk of morcellation was performed by using a scalpel.
VCD. This randomized controlled trial investigates the effects of The vaginal cuff was closed using barbed size 0 suture with
two monopolar current modes, coagulation and cut, during unlocked fashion (V-Loc, Covidien, USA). Vaginal cuff suturing was
colpotomy on postoperative vaginal cuff complication rates. The initiated from the right side and attachment of uterosacral ligament
primary outcome was VCD detected by vaginal examination. to upper posterior vagina was included to the first bite. Full
thicknesses of posterior and anterior vaginal walls were also
Materials and methods included and suturing was continued to the left uterosacral ligament
and then the suture was turned back (towards the medial part of
The present study, a randomized controlled trial (Clinicaltrials. vaginal cuff) with 2 additional bites. Barbed suture was cut at the level
gov registry number NCT02879487), was conducted at a university of vaginal cuff to avoid suture related complications (Movie clip S1).
hospital’s department of obstetrics and gynecology, from Septem- Patients were informed about sexual intercourse abstinence for
ber 2016 through January 2018. The institutional Ethical Commit- 6 weeks after surgery. All participants were examined twice during
tee approved the study (approval number: 12-562-16) and the the follow-up period, at 6 and 12 weeks. Patients were asked for
paper is written according to the CONSORT statement. their complaints; vaginal cuff was visualized by speculum
We assessed eligibility of potential participants who were examination and transvaginal ultrasound was performed to detect
scheduled for hysterectomy either for benign or malignant any cuff related lesions such as hematomas or abscesses.
conditions prior to surgery. Potential participants received The primary end point of our study was to compare the rate of
standardized counseling about the coagulation and cut modes VCD between two study groups. Secondary end points were
for colpotomy at TLH. Written informed consent was obtained from postoperative vaginal cuff abscess, hematoma, blood loss, postop-
each patient. The inclusion criteria were women scheduled for erative hemoglobin drop and duration of hospital stay.
hysterectomy due to benign or malignant gynecologic reasons, and This study was performed as a non-inferiority trial, designating
agreed to randomization for the present study. Exclusion criteria cut, the commonly used method for cuff opening, as the
were as follows: suspicion for a pregnancy, uterine size exceeded comparison for the effects of coagulation toward vaginal cuff
20 weeks’ gestation to constitute a more standardized cohort, dehiscence. The incidence of vaginal cuff dehiscence was
previous radiation therapy, contraindication for Trendelenburg calculated as 0.2% according to the data obtained from our
position and/or high intraabdominal pressure, clinical advanced previous surgeries. The number of patients required for each group
stage malignant disease, conversion to laparotomy before comple- was determined on the basis of the non-inferiority hypothesis. For
tion of colpotomy incision and detachment of uterus from the non-inferiority of the coagulation group versus cut group, a
vagina. Demographic data, indications for surgery, intra- and post- maximum difference of 1.5% (margin of non-inferiority) on the
operative data were recorded were recorded along with primary incidence of vaginal cuff dehiscence was considered as acceptable.
and other outcome parameters. Therefore, we calculated that a study with 95 patients per group
Following application of inclusion and exclusion criteria the would have at least 80% power, with one-sided type I error of 0.05.
enrolled participants were randomized to one of the following two Taking into consideration of the 10% dropout rate, we decided to
groups: monopolar coagulation mode vs monopolar cut mode at the enroll 105 patients in each group.
stage of colpotomy. Randomization was performed using sealed Data analyses were performed by using SPSS Version 21.0 (IBM
envelopes. At the beginning of the study 210 envelopes were Corporation, Armonk, NYC, USA). Shapiro-Wilk test was used to
prepared,105 for each group, according to the sample size calculation. test distribution of normality. Differences between groups for
The envelopes were kept in the operating room and an envelope was categorical variables were analyzed by chi-square test and the
selected randomly at the stage of colpotomy and the surgeon was comparisons of continuous variables between groups were
notified of the randomization assignment. All surgeries were analyzed by Student’s t-test according to results of their normality
performed by the same surgeon (S.T.) with assistance of a fellow. tests. P value less than 0.05 was considered statistically significant.
The participants were blinded to the technique performed. In
addition, the outcome adjudicator was blinded to the colpotomy Results
technique. All patients were evaluated by the same author (S.T.) at
6 and 12 weeks following surgery. From September 2016 through January 2018 we assessed a total
All patients underwent TLH using a standardized approach. The of 217 women for eligibility. Seven of them excluded from the
operation was performed under general anesthesia in lithotomy study because of clinical advanced stage malignancy (n = 3),
position and a single dose of prophylactic antibiotic was given. extremely large uterus (n = 3) and lung disease preventing high
After perineal and vaginal disinfection with polyvinylpyrrolidone intraabdominal pressure (n = 1). Then, 210 participants were
iodine 10% (Batticon1, Adeka, Samsun, Turkey) the cervix is enrolled and randomized during the study period, 105 to each
grasped with Pozzi tenaculum forceps and a uterine manipulator group (Fig. 1). During the post-operative follow-up period five from
was inserted to assist the surgery. A 10-mm, 0-degree laparoscope coagulation arm and six from cut arm were lost to follow-up within
was used in all cases. Vessel sealing was performed using the first 12 weeks. All patients who could not be followed-up
conventional bipolar graspers (RoBi rotating bipolar forceps, indicated that they lived in another city at a long distance. Finally,
Karl Storz, Tuttlingen, Germany) or advanced bipolar devices we analyzed results of 100 participant in coagulation arm and 99
(e.g., LigaSure, Covidien-Medtronic, Dublin, Ireland). participants in cut arm. The mean age and BMI of the trial
Colpotomy was performed by circumferential vaginal incision population were 52.1 9.0 years and 29.1 4.0 kg/m2, respectively.
with monopolar hook using a 35 W pure cut or coagulation current Patient characteristics and indications for surgeries are shown in
(ForceTriad Energy Platform, Medtronic, MN) according to Table 1. There were no statistically significant differences between
randomization. While 30–40 W is the most commonly used the study groups regarding demographics. The indications for
setting for gynecologic laparoscopy worldwide, we preferred surgery were similar between the groups. The rate of premalignant
35 W for all participants for standardization. Bipolar energy set at or malignant indications were similar between the groups (48% vs
40 W (ForceTriad Energy Platform, Medtronic, MN) applied with 44.4%, P = 0.670). Fifty-eight patients had previous abdominal or
40 S. Taşkın et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 234 (2019) 38–42
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