Appendicitis
Conditions
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
The securing the base of appendix by endoloop.
The securing the base of appendix by Stapler.
The securing the base of appendix by Hem-o-lok clip.
The securing the base of appendix by DS clip.
Sponsors
Study design
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
Inclusion criteria
* Patient with accute appendicits
Exclusion criteria
* Patient younger than 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Morbidity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-perative Complications | 120 min. | Complications that appear during operative procedure |
| Postoperative Complications | 30 days | Complications that appear after operative procedure |
| Operative Time | 120 min. | Time of operative procedure |
| Time of Application | 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 |
| Hospital Stay | 30 days | Length of hospitalization |
Countries
Bosnia and Herzegovina
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 120 |
Baseline characteristics
| Characteristic | Laparoscopic Appendectomy. Endoloop. | Laparoscopic Appendectomy. Stapler | Laparoscopic Appendectomy. Hem-o-lok Clip | Laparoscopic Appendectomy. DS Clip | Total |
|---|---|---|---|---|---|
| Age, Continuous | 31.17 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 Participants | 15 Participants | 17 Participants | 13 Participants | 61 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 13 Participants | 17 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laparoscopic Appendectomy. Endoloop. | Overall Morbidity | 0 Participants |
| Laparoscopic Appendectomy. Stapler | Overall Morbidity | 0 Participants |
| Laparoscopic Appendectomy. Hem-o-lok Clip | Overall Morbidity | 0 Participants |
| Laparoscopic Appendectomy. DS Clip | Overall Morbidity | 0 Participants |
Hospital Stay
Length of hospitalization
Time frame: 30 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Appendectomy. Endoloop. | Hospital Stay | 2.17 days | Standard Deviation 0.7 |
| Laparoscopic Appendectomy. Stapler | Hospital Stay | 2.20 days | Standard Deviation 0.71 |
| Laparoscopic Appendectomy. Hem-o-lok Clip | Hospital Stay | 2.23 days | Standard Deviation 0.78 |
| Laparoscopic Appendectomy. DS Clip | Hospital Stay | 2.37 days | Standard Deviation 0.72 |
Intra-perative Complications
Complications that appear during operative procedure
Time frame: 120 min.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laparoscopic Appendectomy. Endoloop. | Intra-perative Complications | 0 Participants |
| Laparoscopic Appendectomy. Stapler | Intra-perative Complications | 0 Participants |
| Laparoscopic Appendectomy. Hem-o-lok Clip | Intra-perative Complications | 0 Participants |
| Laparoscopic Appendectomy. DS Clip | Intra-perative Complications | 0 Participants |
Operative Time
Time of operative procedure
Time frame: 120 min.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Appendectomy. Endoloop. | Operative Time | 46.0 minutes | Standard Deviation 7.07 |
| Laparoscopic Appendectomy. Stapler | Operative Time | 39.37 minutes | Standard Deviation 7.2 |
| Laparoscopic Appendectomy. Hem-o-lok Clip | Operative Time | 42.83 minutes | Standard Deviation 6.52 |
| Laparoscopic Appendectomy. DS Clip | Operative Time | 47.47 minutes | Standard Deviation 6.2 |
Postoperative Complications
Complications that appear after operative procedure
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laparoscopic Appendectomy. Endoloop. | Postoperative Complications | 0 Participants |
| Laparoscopic Appendectomy. Stapler | Postoperative Complications | 0 Participants |
| Laparoscopic Appendectomy. Hem-o-lok Clip | Postoperative Complications | 0 Participants |
| Laparoscopic Appendectomy. DS Clip | Postoperative Complications | 0 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Appendectomy. Endoloop. | Time of Application | 195.50 seconds | Standard Deviation 62.13 |
| Laparoscopic Appendectomy. Stapler | Time of Application | 19.87 seconds | Standard Deviation 4.64 |
| Laparoscopic Appendectomy. Hem-o-lok Clip | Time of Application | 63.90 seconds | Standard Deviation 10.31 |
| Laparoscopic Appendectomy. DS Clip | Time of Application | 63.77 seconds | Standard Deviation 27.8 |