Trial Outcomes & Findings for Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy (NCT NCT02941640)

Results Overview

Overall morbidity following the securing of the base of the appendix, defined as any adverse event occurring from the time of securing the base of the appendix until the 30th day.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

30 days

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Laparoscopic Appendectomy. Endoloop. Laparoscopic appendectomy. The securing the base of appendix by endo-loop. Laparoscopic appendectomy: The securing the base of appendix by endoloop. Endoloop	Laparoscopic Appendectomy. Stapler Laparoscopic appendectomy. The securing the base of appendix by stapler. Laparoscopic appendectomy: The securing the base of appendix by Stapler. Stapler	Laparoscopic Appendectomy. Hem-o-lok Clip Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip. Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip. Hem-o-lok clip	Laparoscopic Appendectomy. DS Clip Laparoscopic appendectomy.The securing the base of appendix by DS clip. Laparoscopic appendectomy: The securing the base of appendix by DS clip. DS clip
Overall Study STARTED	30	30	30	30
Overall Study COMPLETED	30	30	30	30
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laparoscopic Appendectomy. Endoloop. n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by endo-loop. Laparoscopic appendectomy: The securing the base of appendix by endoloop. Endoloop	Laparoscopic Appendectomy. Stapler n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by stapler. Laparoscopic appendectomy: The securing the base of appendix by Stapler. Stapler	Laparoscopic Appendectomy. Hem-o-lok Clip n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip. Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip. Hem-o-lok clip	Laparoscopic Appendectomy. DS Clip n=30 Participants Laparoscopic appendectomy.The securing the base of appendix by DS clip. Laparoscopic appendectomy: The securing the base of appendix by DS clip. DS clip	Total n=120 Participants Total of all reporting groups
Age, Continuous	31.17 years STANDARD_DEVIATION 13.45 • n=5 Participants	30.93 years STANDARD_DEVIATION 12.34 • n=7 Participants	32.63 years STANDARD_DEVIATION 13.97 • n=5 Participants	29.53 years STANDARD_DEVIATION 14.65 • n=4 Participants	31.07 years STANDARD_DEVIATION 13.50 • n=21 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants	13 Participants n=4 Participants	61 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	17 Participants n=4 Participants	59 Participants n=21 Participants

PRIMARY outcome

Timeframe: 30 days

Overall morbidity following the securing of the base of the appendix, defined as any adverse event occurring from the time of securing the base of the appendix until the 30th day.

Outcome measures

Outcome measures
Measure	Laparoscopic Appendectomy. Endoloop. n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by endo-loop. Laparoscopic appendectomy: The securing the base of appendix by endoloop. Endoloop	Laparoscopic Appendectomy. Stapler n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by stapler. Laparoscopic appendectomy: The securing the base of appendix by Stapler. Stapler	Laparoscopic Appendectomy. Hem-o-lok Clip n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip. Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip. Hem-o-lok clip	Laparoscopic Appendectomy. DS Clip n=30 Participants Laparoscopic appendectomy.The securing the base of appendix by DS clip. Laparoscopic appendectomy: The securing the base of appendix by DS clip. DS clip
Overall Morbidity	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 120 min.

Complications that appear during operative procedure

Outcome measures

Outcome measures
Measure	Laparoscopic Appendectomy. Endoloop. n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by endo-loop. Laparoscopic appendectomy: The securing the base of appendix by endoloop. Endoloop	Laparoscopic Appendectomy. Stapler n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by stapler. Laparoscopic appendectomy: The securing the base of appendix by Stapler. Stapler	Laparoscopic Appendectomy. Hem-o-lok Clip n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip. Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip. Hem-o-lok clip	Laparoscopic Appendectomy. DS Clip n=30 Participants Laparoscopic appendectomy.The securing the base of appendix by DS clip. Laparoscopic appendectomy: The securing the base of appendix by DS clip. DS clip
Intra-perative Complications	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Complications that appear after operative procedure

Outcome measures

Outcome measures
Measure	Laparoscopic Appendectomy. Endoloop. n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by endo-loop. Laparoscopic appendectomy: The securing the base of appendix by endoloop. Endoloop	Laparoscopic Appendectomy. Stapler n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by stapler. Laparoscopic appendectomy: The securing the base of appendix by Stapler. Stapler	Laparoscopic Appendectomy. Hem-o-lok Clip n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip. Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip. Hem-o-lok clip	Laparoscopic Appendectomy. DS Clip n=30 Participants Laparoscopic appendectomy.The securing the base of appendix by DS clip. Laparoscopic appendectomy: The securing the base of appendix by DS clip. DS clip
Postoperative Complications	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 120 min.

Time of operative procedure

Outcome measures

Outcome measures
Measure	Laparoscopic Appendectomy. Endoloop. n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by endo-loop. Laparoscopic appendectomy: The securing the base of appendix by endoloop. Endoloop	Laparoscopic Appendectomy. Stapler n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by stapler. Laparoscopic appendectomy: The securing the base of appendix by Stapler. Stapler	Laparoscopic Appendectomy. Hem-o-lok Clip n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip. Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip. Hem-o-lok clip	Laparoscopic Appendectomy. DS Clip n=30 Participants Laparoscopic appendectomy.The securing the base of appendix by DS clip. Laparoscopic appendectomy: The securing the base of appendix by DS clip. DS clip
Operative Time	46.0 minutes Standard Deviation 7.07	39.37 minutes Standard Deviation 7.2	42.83 minutes Standard Deviation 6.52	47.47 minutes Standard Deviation 6.2

SECONDARY outcome

Timeframe: 120 min

Time of application of endoloop, stapler, Hem-o-lok and DS clip measured from introducing of instruments to cutting the base of appendix

Outcome measures

Outcome measures
Measure	Laparoscopic Appendectomy. Endoloop. n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by endo-loop. Laparoscopic appendectomy: The securing the base of appendix by endoloop. Endoloop	Laparoscopic Appendectomy. Stapler n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by stapler. Laparoscopic appendectomy: The securing the base of appendix by Stapler. Stapler	Laparoscopic Appendectomy. Hem-o-lok Clip n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip. Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip. Hem-o-lok clip	Laparoscopic Appendectomy. DS Clip n=30 Participants Laparoscopic appendectomy.The securing the base of appendix by DS clip. Laparoscopic appendectomy: The securing the base of appendix by DS clip. DS clip
Time of Application	195.50 seconds Standard Deviation 62.13	19.87 seconds Standard Deviation 4.64	63.90 seconds Standard Deviation 10.31	63.77 seconds Standard Deviation 27.80

SECONDARY outcome

Timeframe: 30 days

Length of hospitalization

Outcome measures

Outcome measures
Measure	Laparoscopic Appendectomy. Endoloop. n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by endo-loop. Laparoscopic appendectomy: The securing the base of appendix by endoloop. Endoloop	Laparoscopic Appendectomy. Stapler n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by stapler. Laparoscopic appendectomy: The securing the base of appendix by Stapler. Stapler	Laparoscopic Appendectomy. Hem-o-lok Clip n=30 Participants Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip. Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip. Hem-o-lok clip	Laparoscopic Appendectomy. DS Clip n=30 Participants Laparoscopic appendectomy.The securing the base of appendix by DS clip. Laparoscopic appendectomy: The securing the base of appendix by DS clip. DS clip
Hospital Stay	2.17 days Standard Deviation 0.70	2.20 days Standard Deviation 0.71	2.23 days Standard Deviation 0.78	2.37 days Standard Deviation 0.72

Adverse Events

Laparoscopic Appendectomy. Endoloop.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laparoscopic Appendectomy. Stapler

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laparoscopic Appendectomy. Hem-o-lok Clip

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laparoscopic Appendectomy. DS Clip

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samir Delibegovic

University Clinical Center Tuzla

Phone: +387 61 149 131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place