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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02941640
Enrollment
120
Registered
2016-10-21
Start date
2016-10-02
Completion date
2017-01-30
Last updated
2017-06-14

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

Conditions

Appendicitis

Keywords

Laparoscopic appendectomy, Endoloop, Stapler, Hem-o-lok clip, DS clip

Brief summary

During laparoscopic appendectomy, the base of the appendix is usually secured by an endoloop ligature or the stapler. Non-absorbable plastic hem-o-lok clip was shown as an alternative technique with which laparoscopic appendectomy was done faster and cheaper than the standard techniques. However, biocompatibility of different materials udes in securing the base of appendix is different. It was observed that stapler's clips made by titanium caused the mildest inflammatory reaction and creation of adhesions. Disadvantages of stapler's are their high price. Titanium clips made for the use in laparoscopic appendectomy are safe and effective option in securing the appendicular stump in laparoscopic appendectomy. They have potential advantages over stapler, because they have the same bio compatibility, and their price is lower.

Detailed description

Prospective study was conducted in the period from 02. October 2016 to 30. December 2016. The patients were randomly divided into four groups; in the first group, the base of the appendix was secured using one endoloop ligature, in the second group using the 45-mm stapler, in third group using only one non-absorbable Hem-o-lok clip and in fourth group using titanium DS clip. Patients were assessed for eligibility at the emergency station by the surgeon on-call once the diagnosis of acute appendicitis was established. A dedicated study nurse assigned randomly to Endoloop (E group) or Stapler (S group), or Hem-o-lock (H group), or DS clip (DS group) by picking out of a box and opening a sealed opaque randomization envelope in operating theatre. The details of the allocated treatments (''E'' or ''S'', or (''H'' or (''Ds'' ) were given on cards contained in sealed opaque envelopes. All sealed opaque envelopes were previously prepared with a 1 : 1 ratio, well shuffled, and put into a box by the dedicated study nurse. No blinding was performed. Data collected included age, gender, surgery time, time of hem-o-lok clip application, hospital stay, costs associated with these and intra- and post-operative complications. Technique The patient was placed in supine position, combined with Trendelenburg position and left lateral position (10º - 15º, incline towards the surgeon). The surgeon used the French position (between legs of patient) and an assistant stood on the left side, and monitor was on the right side of the patient. The bladder was decompressed with the Foley catheter to avoid an injury during insertion of the supra-pubic ports. Pneumoperitoneum was established with the Veress needle through the umbilicus and then an endoscope was introduced. Under direct vision, one 12 mm trocar was inserted in suprapubic region, a little to the left, and 5 mm trocar in the right lower quadrant, to the level of the first 12 mm port, in order to acquire triangulation. After that the abdominal cavity was inspected. When the decision was made to perform appendectomy, mesoappendix was mobilized and dissected using an harmonic scalpel (Ethicon, Endosurgery, Cincinnati, OH). In the first group, the base of the appendix was secured using one endoloop, and on the distal part which would be removed, another endoloop was used. In the second group, the appendix was secured by a 45 mm stapler (thick charge) (Ethicon, Endosurgery, Cincinnati, OH). In the third group, one hem-o-lok clip, size XL (Hem-o-lock, Weck Closure Systems, Research Triangle Park, NC, USA) was placed on the base the appendix by a special applier for the hem-o-lok clip, and on the distal part which would be removed, another clip was used. In the fourth group, one titanium DS clip (Aesculap AG, Tuttlingen, Germany) was placed on the base of appendix by endoscopic clip applier (12 mm) and on the distal part which would be removed, another DS clip was used.

Interventions

PROCEDUREE group

The securing the base of appendix by endoloop.

PROCEDURES group

The securing the base of appendix by Stapler.

PROCEDUREH group

The securing the base of appendix by Hem-o-lok clip.

PROCEDUREDS group

The securing the base of appendix by DS clip.

DEVICEEndoloop
DEVICEStapler
DEVICEHem-o-lok clip
DEVICEDS clip

Sponsors

University Clinical Center Tuzla
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The study included 120 patients randomly divided into four groups with 30 patients in each. The study was not blinded. The nurse designated for participation in this study allocated the patients randomly into four groups by selecting a sealed opaque envelope from a box and opening it in the operating theatre. A card inside the envelope contained name of the treatment. All the envelopes were prepared in advance in a ratio of 1:4, shuffled well, and placed in the box by the same nurse.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patient with accute appendicits

Exclusion criteria

* Patient younger than 18 years

Design outcomes

Primary

MeasureTime frameDescription
Overall Morbidity30 daysOverall 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.

Secondary

MeasureTime frameDescription
Intra-perative Complications120 min.Complications that appear during operative procedure
Postoperative Complications30 daysComplications that appear after operative procedure
Operative Time120 min.Time of operative procedure
Time of Application120 minTime of application of endoloop, stapler, Hem-o-lok and DS clip measured from introducing of instruments to cutting the base of appendix
Hospital Stay30 daysLength of hospitalization

Countries

Bosnia and Herzegovina

Participant flow

Participants by arm

ArmCount
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
30
Laparoscopic Appendectomy. Stapler
Laparoscopic appendectomy. The securing the base of appendix by stapler. Laparoscopic appendectomy: The securing the base of appendix by Stapler. Stapler
30
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
30
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
30
Total120

Baseline characteristics

CharacteristicLaparoscopic Appendectomy. Endoloop.Laparoscopic Appendectomy. StaplerLaparoscopic Appendectomy. Hem-o-lok ClipLaparoscopic Appendectomy. DS ClipTotal
Age, Continuous31.17 years
STANDARD_DEVIATION 13.45
30.93 years
STANDARD_DEVIATION 12.34
32.63 years
STANDARD_DEVIATION 13.97
29.53 years
STANDARD_DEVIATION 14.65
31.07 years
STANDARD_DEVIATION 13.5
Sex: Female, Male
Female
16 Participants15 Participants17 Participants13 Participants61 Participants
Sex: Female, Male
Male
14 Participants15 Participants13 Participants17 Participants59 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 300 / 300 / 30
other
Total, other adverse events
0 / 300 / 300 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 300 / 300 / 30

Outcome results

Primary

Overall Morbidity

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.

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Laparoscopic Appendectomy. Endoloop.Overall Morbidity0 Participants
Laparoscopic Appendectomy. StaplerOverall Morbidity0 Participants
Laparoscopic Appendectomy. Hem-o-lok ClipOverall Morbidity0 Participants
Laparoscopic Appendectomy. DS ClipOverall Morbidity0 Participants
Secondary

Hospital Stay

Length of hospitalization

Time frame: 30 days

ArmMeasureValue (MEDIAN)Dispersion
Laparoscopic Appendectomy. Endoloop.Hospital Stay2.17 daysStandard Deviation 0.7
Laparoscopic Appendectomy. StaplerHospital Stay2.20 daysStandard Deviation 0.71
Laparoscopic Appendectomy. Hem-o-lok ClipHospital Stay2.23 daysStandard Deviation 0.78
Laparoscopic Appendectomy. DS ClipHospital Stay2.37 daysStandard Deviation 0.72
Secondary

Intra-perative Complications

Complications that appear during operative procedure

Time frame: 120 min.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Laparoscopic Appendectomy. Endoloop.Intra-perative Complications0 Participants
Laparoscopic Appendectomy. StaplerIntra-perative Complications0 Participants
Laparoscopic Appendectomy. Hem-o-lok ClipIntra-perative Complications0 Participants
Laparoscopic Appendectomy. DS ClipIntra-perative Complications0 Participants
Secondary

Operative Time

Time of operative procedure

Time frame: 120 min.

ArmMeasureValue (MEAN)Dispersion
Laparoscopic Appendectomy. Endoloop.Operative Time46.0 minutesStandard Deviation 7.07
Laparoscopic Appendectomy. StaplerOperative Time39.37 minutesStandard Deviation 7.2
Laparoscopic Appendectomy. Hem-o-lok ClipOperative Time42.83 minutesStandard Deviation 6.52
Laparoscopic Appendectomy. DS ClipOperative Time47.47 minutesStandard Deviation 6.2
p-value: <0.0001ANOVA
Comparison: Post hoc analysis was done by Tukey test.p-value: 0.001Tukey post hoc test
p-value: <0.0001Tukey post hoc test
p-value: 0.044Tukey post hoc test
p-value: <0.272Tukey post hoc test
p-value: 0.835Tukey post hoc test
p-value: 0.199Tukey post hoc test
Secondary

Postoperative Complications

Complications that appear after operative procedure

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Laparoscopic Appendectomy. Endoloop.Postoperative Complications0 Participants
Laparoscopic Appendectomy. StaplerPostoperative Complications0 Participants
Laparoscopic Appendectomy. Hem-o-lok ClipPostoperative Complications0 Participants
Laparoscopic Appendectomy. DS ClipPostoperative Complications0 Participants
Secondary

Time of Application

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

Time frame: 120 min

ArmMeasureValue (MEAN)Dispersion
Laparoscopic Appendectomy. Endoloop.Time of Application195.50 secondsStandard Deviation 62.13
Laparoscopic Appendectomy. StaplerTime of Application19.87 secondsStandard Deviation 4.64
Laparoscopic Appendectomy. Hem-o-lok ClipTime of Application63.90 secondsStandard Deviation 10.31
Laparoscopic Appendectomy. DS ClipTime of Application63.77 secondsStandard Deviation 27.8
p-value: 1Tukey post hoc test
p-value: <0.0001ANOVA
p-value: <0.0001Tukey post hoc test
p-value: <0.0001Tukey post hoc test
p-value: <0.0001Tukey post hoc test
p-value: <0.0001Tukey post hoc test
p-value: <0.0001Tukey post hoc test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026